Glossary Terms (Simple List)
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Detectability (D)
The ability to discover or determine the existence, presence, or fact of a hazard. (TR54-2) (TR54-3)
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Detection
The ability to discover or identify a defect or failure. (TR44)
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Detergent
A synthetic wetting agent and emulsifier that can be added to a solvent to improve its cleaning efficiency. (TR70)
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Deterministic Leak Test Method
A method in which the leakage event being detected or measured is based on phenomena that follow a predictable chain of events. In addition, the measure of leak detection is based on physicochemical technologies that are readily controlled and monitored, yielding objective quantitative data. (TR86)
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Development Reports
Documentation and description of work done during the early phases of development. The goal is to document information about the way the process works and to document why key choices were made in selecting the specifics of the process (e.g., flow rate or temperature). These documents can serve as a reference during investigations of discrepancies and during the design of specific Validation and characterization studies.(TR14) (TR 42)
Documentation and description of work done during the early phases of development (Stage 1). The goal is to document information about the way the process works and to document why key choices were made in selecting the specifics of the process (e.g., flow rate or temperature). These documents can serve as a reference during investigations of deviations and during the design of specific validation and process characterization studies.(TR60)
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Deviation
Departure or digression from set parameters. (TR58)
Data or a result outside of the expected range or an unfulfilled requirement; it may be called nonconformity, defect, discrepancy, out-of-specification, out-of-limit, or adverse trend. (TR88)
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Dew Point
The temperature at which a vapor or vapors become saturated. (TR51)
The temperature to which a given parcel of humid air must be cooled, at constant barometric pressure, for water vapor to condense into water. The condensed water is called dew. The dew point is a saturation temperature. The dew point is associated with Relative Humidity (RH). A high RH indicates that the dew point is closer to the current air temperature. RH of 100% indicates the dew point is equal to the current temperature and the air is maximally saturated with water. When the dew point remains constant and temperature increases, RH will decrease. (TR55)
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Dextrans
Complex, branched, high molecular weight polysaccharides made of many glucose molecules joined into chains of varying lengths and branches. (TR41)
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Diafiltration
The convective elimination of permeable solutes by the addition of fresh solvent to the retentate. (TR15)
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Diavolume (DV)
A volume equal to the retentate volume to which a diafiltration buffer is added. (TR15)